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A Phase II Study to Evaluate Overall Response Rate of BAY 43-9006 (Sorafenib) Combined With Docetaxel and Cisplatin or Oxaliplatin in the Treatment of Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Trial Information

A Phase II Study to Evaluate Overall Response Rate of BAY 43-9006 (Sorafenib) Combined With Docetaxel and Cisplatin or Oxaliplatin in the Treatment of Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

PRIMARY OBJECTIVES:

I. To evaluate the response rate (CR and PR) of the combination of BAY 43-9006 with
docetaxel and cisplatin or oxaliplatin in patients with gastric and GEJ adenocarcinoma.

II. To evaluate the progression-free survival (PFS) and overall survival. III. To evaluate
the toxicities of BAY 43-9006 in patients with advanced and metastatic gastric or GEJ
adenocarcinoma combined with docetaxel/cisplatin or docetaxel/oxaliplatin.

IV. To evaluate Raf status in the tumor and to correlate response and PFS to the presence or
absence of an activating mutation in B-Raf.

V. To analyze the pharmacokinetic and pharmacogenetic properties of BAY 43-9006 including
angiogenesis, monooxygenases, polymorphisms and MDR. This study will be conducted via the
E1Y03 mechanism.

Patients receive oral sorafenib twice daily on days 1-21. Patients also receive docetaxel IV
over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 3 years.

Inclusion Criteria:

- Patients must have measurable, histologically confirmed, advanced unresectable or
metastatic gastric or GEJ adenocarcinoma; imaging studies must be conducted within 4
weeks of study entry

- For patients with GEJ adenocarcinoma, the tumor location should be specified using
the Siewert classification used in other NCI-sponsored Phase II studies in these
disease sites

- Patients must have an ECOG performance status of 0-1

- Patients may have had adjuvant chemotherapy or chemoradiation therapy, with or
without 5-Fluorouracil if the treatment was performed more than 6 months before any
evidence of recurrent or metastatic disease

- Patients must NOT have had any previous radiotherapy, chemotherapy or investigational
therapies, particularly inhibitors of tyrosine Kinases, signal transduction or
angiogenesis in the treatment for THEIR RECURRENT and/or METASTATIC gastric or GEJ
adenocarcinoma

- Patients may not be receiving any other investigational agents

- The effects of BAY 43-9006 on the developing human fetus at the recommended
therapeutic dose are unknown; for this reason and because raf kinase inhibitor agents
as well as other therapeutic agents used in this trial are known to be teratogenic,
women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and
for the duration of study participation; should a woman become pregnant or suspect
she is pregnant while participating in this study, she should inform her treating
physician immediately; women must not be pregnant or breast-feeding; all females of
childbearing potential must have a blood or urine test within 2 weeks prior to
randomization to rule out pregnancy

- Women of childbearing potential and sexually active males must be strongly advised to
use an accepted and effective method of contraception

- Patients with immune deficiency are at increased risk of lethal infections when
treated with marrow-suppressive therapy; therefore, HIV-positive patients receiving
combination antiretroviral therapy are excluded from the study because of possible
pharmacokinetic interactions with BAY 43-9006

- Patients must not have known brain metastases because of their poor prognosis and
because they often develop progressive neurologic dysfunction that would confound the
evaluation of neurologic and other adverse events

- Patients must not have a history of allergic reactions attributed to compounds of
similar chemical or biologic composition to BAY 43-9006

- Absolute Granulocyte Count >= 1,500/mm^3

- Platelet Count >= 100,000/mm^3

- White Blood Count >= 3,000/mm^3

- Serum Creatinine =< 1.5 mg/dl

- Total Bilirubin =< 2.0 mg/dl

- AST/ALT/Alk phos =< 2.5 x ULN

- Patients must not have an acute active infection with significant clinical
intervention per physician's discretion

- Previous or concurrent malignancies are not allowed, except:

- Non-melanoma skin cancer and in situ cervical cancer

- Treated cancer from which the patient has been continuously disease-free for
more than five years

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